| Revision as of 10:02, 31 October 2011 editBeetstra (talk | contribs)Edit filter managers, Administrators172,031 edits Script assisted update of identifiers for the Chem/Drugbox validation project (updated: 'DrugBank', 'UNII').← Previous edit |
Latest revision as of 13:42, 21 December 2024 edit undoPol098 (talk | contribs)Extended confirmed users, Pending changes reviewers118,258 edits →top: reinstated: Insulin glargine was patented, but the patent expired in most jurisdictions in 2014. |
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{{Short description|Long-acting insulin}} |
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{{Drugbox |
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{{Use dmy dates|date=September 2022}} |
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| IUPAC_name = Recombinant human insulin |
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{{cs1 config |name-list-style=vanc |display-authors=6}} |
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{{Infobox drug |
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| Verifiedfields = changed |
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| verifiedrevid = 458271727 |
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| image = Toujeo 300 IU-ml inj.jpg |
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| width = |
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| alt = |
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| caption = Toujeo branded insulin glargine |
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<!--Clinical data--> |
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<!-- Clinical data -->| pronounce = |
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| tradename = |
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| tradename = Lantus, others |
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| Drugs.com = {{drugs.com|monograph|insulin_glargine}} |
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| Drugs.com = {{drugs.com|monograph|insulin_glargine}} |
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| MedlinePlus = a600027 |
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| MedlinePlus = a600027 |
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| DailyMedID = Insulin glargine |
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| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> |
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| pregnancy_US = C |
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| pregnancy_AU = B3 |
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| pregnancy_AU_comment = <ref name="Drugs.com pregnancy">{{cite web | title=Insulin glargine Use During Pregnancy | website=Drugs.com | date=6 April 2020 | url=https://www.drugs.com/pregnancy/insulin-glargine.html | access-date=4 September 2020 | archive-date=21 October 2020 | archive-url=https://web.archive.org/web/20201021163744/https://www.drugs.com/pregnancy/insulin-glargine.html | url-status=live }}</ref> |
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| legal_AU = <!-- Unscheduled / S2 / S4 / S8 --> |
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| pregnancy_category = |
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| routes_of_administration = ] |
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| class = |
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| ATC_prefix = A10 |
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| ATC_suffix = AE04 |
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| ATC_supplemental = |
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| biosimilars = insulin glargine-aglr, insulin glargine-yfgn, Abasaglar, Rezvoglar, Semglee |
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<!-- Legal status -->| legal_AU = S4 |
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| legal_AU_comment = |
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| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F --> |
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| legal_BR_comment = |
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| legal_CA = Rx-only |
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| legal_CA_comment = /{{nbsp}}Schedule D<ref>{{cite web | title=Summary Basis of Decision - Semglee | website=Health Canada | date=23 August 2022 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?lang=en&linkID=SBD00600&lang=en | access-date=29 September 2022 | archive-date=29 September 2022 | archive-url=https://web.archive.org/web/20220929045655/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?lang=en&linkID=SBD00600&lang=en | url-status=live }}</ref> |
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| legal_DE = <!-- Anlage I, II, III or Unscheduled --> |
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| legal_DE_comment = |
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| legal_NZ = <!-- Class A, B, C --> |
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| legal_NZ_comment = |
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| legal_UK = POM |
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| legal_UK = POM |
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| legal_UK_comment = <ref>{{cite web | title=Lantus 100 units/ml solution for injection in a cartridge - Summary of Product Characteristics (SmPC) | website=(emc) | url=https://www.medicines.org.uk/emc/product/2376/smpc | access-date=7 May 2020 | archive-date=9 January 2021 | archive-url=https://web.archive.org/web/20210109065757/https://www.medicines.org.uk/emc/product/2376/smpc | url-status=live }}</ref> |
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| legal_US = Rx-only |
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| legal_US = Rx-only |
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| legal_US_comment = <ref>{{cite web | title=Lantus- insulin glargine injection, solution Lantus SoloStar- insulin glargine injection, solution | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a | access-date=29 July 2021 | archive-date=29 July 2021 | archive-url=https://web.archive.org/web/20210729050000/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a | url-status=live }}</ref> |
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| routes_of_administration = Subcutaneous |
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| legal_EU = Rx-only |
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| legal_EU_comment = <ref>{{cite web | title=Lantus EPAR | website=] (EMA) | date=8 May 2009 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/lantus | access-date=28 July 2021 | archive-date=4 August 2020 | archive-url=https://web.archive.org/web/20200804155233/https://www.ema.europa.eu/en/medicines/human/EPAR/lantus | url-status=live }}</ref><ref>{{cite web | title=Toujeo EPAR | website=] (EMA) | date=11 May 2009 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/toujeo-previously-optisulin | access-date=28 July 2021 | archive-date=29 July 2021 | archive-url=https://web.archive.org/web/20210729050012/https://www.ema.europa.eu/en/medicines/human/EPAR/toujeo-previously-optisulin | url-status=live }}</ref> |
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| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV --> |
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| legal_UN_comment = |
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| legal_status = Rx-only |
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<!-- Pharmacokinetic data -->| bioavailability = |
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<!--Identifiers--> |
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| protein_bound = |
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| metabolism = |
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| metabolites = |
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| onset = ~1 hour<ref name=AHFS2018/> |
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| elimination_half-life = |
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| duration_of_action = 24–36 hours<ref name=AHFS2018/> |
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| excretion = <!-- Identifiers --> |
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| CAS_number_Ref = {{cascite|correct|??}} |
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| CAS_number = 160337-95-1 |
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| CAS_number = 160337-95-1 |
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| ATC_prefix = A10 |
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| CAS_supplemental = |
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| ATC_suffix = AE04 |
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| PubChem = |
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| IUPHAR_ligand = 7572 |
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
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| DrugBank = DB00047 |
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| DrugBank = DB00047 |
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| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}} |
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| UNII_Ref = {{fdacite|correct|FDA}} |
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| ChemSpiderID = none |
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| UNII = <!-- blanked - oldvalue: 2ZM8CX04RZ --> |
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| UNII_Ref = {{fdacite|changed|FDA}} |
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| UNII = 2ZM8CX04RZ |
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| KEGG_Ref = {{keggcite|correct|kegg}} |
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| KEGG = D03250 |
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| KEGG = D03250 |
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| ChemSpiderID = NA |
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| ChEBI_Ref = |
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| ChEBI = |
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| ChEMBL_Ref = |
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<!--Chemical data--> |
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| ChEMBL = |
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| C=267 | H=404 | N=72 | O=78 | S=6 |
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| NIAID_ChemDB = |
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| molecular_weight = 6063 g/mol |
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| PDB_ligand = |
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| synonyms = <!-- Chemical and physical data --> |
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| IUPAC_name = Recombinant human insulin |
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| C = 267 |
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| H = 404 |
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| N = 72 |
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| O = 78 |
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| S = 6 |
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| SMILES = |
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| Jmol = |
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| StdInChI = |
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| StdInChI_comment = |
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| StdInChIKey = |
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| density = |
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| density_notes = |
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| melting_point = |
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| solubility = |
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| specific_rotation = |
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}} |
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}} |
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'''Insulin glargine''', marketed by ] under the name '''Lantus''', is a long-acting basal ], given once daily to help control the ] level of those with ]. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours, with a "peakless" profile (according to the Lantus package insert). Pharmacokinetically, it resembles basal insulin secretion of non-diabetic pancreatic beta cells. Sometimes, in type 2 diabetes and in combination with a short acting ] (drugs which stimulate the pancreas to make more insulin), it can offer moderate control of serum glucose levels. In the absence of endogenous insulin—Type 1 diabetes, depleted ] (in some cases) or ] in late stage—Lantus needs the support of fast acting insulin taken with food to reduce the effect of prandially derived glucose. |
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<!-- Definition and medical uses --> |
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==Benefit== |
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'''Insulin glargine''' sold under the brand name '''Lantus''' among others is a long-acting ] form of ], used in the management of ] and ].<ref name=AHFS2018/> It is ].<ref name=AHFS2018/> Effects generally begin an hour after use.<ref name=AHFS2018/> |
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<!-- Side effects and mechanism --> |
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When standard NPH is administered at night, its peak of action can coincide with the lower serum glucose levels associated with nocturnal metabolism potentially setting the stage for nocturnal ]. Lantus is associated with a lower risk of nocturnal hypoglycaemia. |
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Common side effects include ], problems at the site of injection, itchiness, and weight gain.<ref name=AHFS2018/> Other serious side effects include ].<ref name=AHFS2018/> ] rather than insulin glargine is generally preferred in ].<ref name=BNF76>{{cite book |title=British national formulary: BNF 76 |date=2018 |publisher=Pharmaceutical Press |isbn=9780857113382|page=701|edition=76th}}</ref> After injection, ]s slowly release insulin for about 24 hours.<ref name=AHFS2018/> This insulin causes body tissues to absorb ] from the blood and decreases glucose production by the liver.<ref name=AHFS2018/> |
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<!-- Society and culture --> |
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== Pharmacological specifications== |
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Insulin glargine was patented, but the patent expired in most jurisdictions in 2014. It was approved for medical use in the United States in 2000.<ref name=AHFS2018>{{cite web |title=Insulin Glargine Monograph for Professionals |url=https://www.drugs.com/monograph/insulin-glargine.html |website=Drugs.com |publisher=AHFS |access-date=23 December 2018 |archive-date=5 December 2020 |archive-url=https://web.archive.org/web/20201205095655/https://www.drugs.com/monograph/insulin-glargine.html |url-status=live }}</ref> It is on the ].<ref name="WHO23rd">{{cite book | vauthors = ((World Health Organization)) | title = The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023) | year = 2023 | hdl = 10665/371090 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2023.02 | hdl-access=free }}</ref> In 2022, it was the 28th most commonly prescribed medication in the United States, with more than 18{{nbsp}}million prescriptions.<ref>{{cite web | title=The Top 300 of 2022 | url=https://clincalc.com/DrugStats/Top300Drugs.aspx | website=ClinCalc | access-date=30 August 2024 | archive-date=30 August 2024 | archive-url=https://web.archive.org/web/20240830202410/https://clincalc.com/DrugStats/Top300Drugs.aspx | url-status=live }}</ref><ref>{{cite web | title = Insulin Glargine Drug Usage Statistics, United States, 2013 - 2022 | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/InsulinGlargine | access-date = 30 August 2024 }}</ref> In July 2021, the US ] (FDA) approved an interchangeable ] insulin product called Semglee (insulin glargine-yfgn) for the treatment of diabetes.<ref name="FDA PR 20210728" /> |
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===Mechanism of action (pharmacodynamics)=== |
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Insulin glargine have substitution of glycine for asparagine at A21 and two arginines added to the carboxy terminal of B chain. This allows insulin glargine to form a precipitate (hexamer) when injected subcutaneously into the patient. It can achieve a peakless level for at least 24 hours. |
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==Medical uses== |
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===Acceptance and repartition in the body (pharmacokinetic)=== |
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{{Update|documentation|date=January 2022}} |
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The long-acting insulin class, which includes insulin glargine, do not appear much better than ],<ref name=":0">{{cite journal | vauthors = Hemmingsen B, Metzendorf MI, Richter B | title = (Ultra-)long-acting insulin analogues for people with type 1 diabetes mellitus | journal = The Cochrane Database of Systematic Reviews | volume = 3 | issue = 4 | pages = CD013498 | date = March 2021 | pmid = 33662147 | pmc = 8094220 | doi = 10.1002/14651858.cd013498.pub2 }}</ref> but do have a greater cost, making them, as of 2010, not cost effective for the treatment of type 2 diabetes.<ref>{{cite journal | vauthors = Waugh N, Cummins E, Royle P, Clar C, Marien M, Richter B, Philip S | title = Newer agents for blood glucose control in type 2 diabetes: systematic review and economic evaluation | journal = Health Technology Assessment | volume = 14 | issue = 36 | pages = 1–248 | date = July 2010 | pmid = 20646668 | doi = 10.3310/hta14360 | doi-access = free }}</ref> In a previous review it was unclear if there is a difference in ], as there was not enough data to determine any differences with respect to long term outcomes,<ref name=Singh2009>{{cite journal | vauthors = Singh SR, Ahmad F, Lal A, Yu C, Bai Z, Bennett H | title = Efficacy and safety of insulin analogues for the management of diabetes mellitus: a meta-analysis | journal = CMAJ | volume = 180 | issue = 4 | pages = 385–397 | date = February 2009 | pmid = 19221352 | pmc = 2638025 | doi = 10.1503/cmaj.081041 }}</ref> however a more recent ] ] did not find clinically significant difference when comparing insulin glargine to NPH insulin, ] or ] in the management of type 1 diabetes in either adults or children over periods of 6 months or longer.<ref name=":0" /> It is not typically the recommended long-acting insulin in the United Kingdom.<ref name=BNF76/> |
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Semglee is indicated to improve glycemic control in adults and children with type 1 diabetes and in adults with type 2 diabetes.<ref name="FDA PR 20210728" /> Semglee is both biosimilar to, and interchangeable with its reference product Lantus (insulin glargine), a long-acting insulin analog.<ref name="FDA PR 20210728" /> |
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Lantus is formulated at an acidic pH 4, where it is completely water soluble. After subcutaneous injection of the acidic solute (which can cause discomfort and a stinging sensation and can be mitigated with the use of the I-port ), when a physiologic pH (approximately 7.4) is achieved the increase in pH causes the insulin to come out of solution resulting in the formation of microcrystals (called insulin hexamers) which then dissociate into insulin monomers, the functional and physiologically active unit of insulin. This gradual process ensures that small amounts of Lantus are released into the body continuously, giving an almost peakless profile. |
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===Mixing with other insulins=== |
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==Usage== |
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The American Diabetes Association say that, unlike some other longer-acting insulins, glargine should not be diluted or mixed with other insulin or solution in the same syringe, due to the low pH of its diluent.<ref>{{cite journal |author=American Diabetes Association | title = Insulin administration | journal = Diabetes Care | volume = 26 | issue = Suppl. 1 | pages = S121–S124 | date = January 2003 | pmid = 12502637 | doi = 10.2337/diacare.26.2007.S121 | doi-access = free }}</ref> However, a 2004 study found that mixing glargine with other insulins did not affect short-term glycemic profile.<ref>{{cite journal | vauthors = Kaplan W, Rodriguez LM, Smith OE, Haymond MW, Heptulla RA | title = Effects of mixing glargine and short-acting insulin analogs on glucose control | journal = Diabetes Care | volume = 27 | issue = 11 | pages = 2739–2740 | date = November 2004 | pmid = 15505016 | doi = 10.2337/diacare.27.11.2739 | doi-access = free }}</ref> |
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===Mixing with other insulin preparations=== |
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Unlike some other longer-acting insulins, Lantus must not be diluted or mixed with other insulin or solution in the same syringe.<ref>American Diabetes Association. (2003). Position statement: Insulin administration. ''Diabetes Care 26''(Suppl. 1), 121–124</ref> |
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==Other information== |
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==Adverse effects== |
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Common side effects include ], problems at the site of injection, itchiness, and weight gain.<ref name=AHFS2018/> Serious side effects include ].<ref name=AHFS2018/> |
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===Development=== |
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As of 2012, tentative evidence shows no association between insulin glargine and ].<ref>{{cite journal | vauthors = Tang X, Yang L, He Z, Liu J | title = Insulin glargine and cancer risk in patients with diabetes: a meta-analysis | journal = PLOS ONE | volume = 7 | issue = 12 | pages = e51814 | date = 2012 | pmid = 23284776 | pmc = 3526637 | doi = 10.1371/journal.pone.0051814 | doi-access = free | bibcode = 2012PLoSO...751814T }}</ref> Previous studies had raised concerns.<ref>{{cite journal | vauthors = Rendell M, Akturk HK, Tella SH | title = Glargine safety, diabetes and cancer | journal = Expert Opinion on Drug Safety | volume = 12 | issue = 2 | pages = 247–263 | date = March 2013 | pmid = 23394441 | doi = 10.1517/14740338.2013.770469 | s2cid = 9224923 }}</ref> |
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The development of Lantus was conducted at Sanofi-Aventis's biotechnology competence center in Frankfurt-Höchst. Sanofi supplies the product to over 100 countries and more than 3,5 million patients worldwide. This makes Lantus Germany's largest and most important export pharmaceutical product. Sanofi-Aventis increased its turn-over with Lantus around 28% to 2,45 Billion €, therefrom 130 Million € in Germany, where approx. 1,8 Mio. diabetics applied this preparation. In 2007 Lantus ranked place 15 on top-selling pharmaceutical products in Germany. |
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When comparing insulin glargine to NPH insulin, insulin detemir or insulin degludec, no significant adverse effects were found in the management of type 1 diabetes in either adults or children in periods of six months or longer.<ref name=":0" /> |
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The investment in the production of Lantus and insulin-pen-manufacturing at the location Frankfurt-Höchst lied at 700 Mio. €. In 2008 a new manufacturing plant was established for further insulin-pen with an investment sum of 150 Mio. €. At Sanofi-Aventis the production of Lantus created 3000 jobs in Berlin and Frankfurt-Höchst. |
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==Pharmacology== |
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On June 9, 2000 the European Commission approbated Sanofi-Aventis Germany Ltd. the launching of Lantus in the entire European Union. The admission was prolonged on June 9, 2005.<ref>, German summary of admission report of ] (PDF)</ref> |
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===Mechanism of action=== |
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==Advantages== |
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Insulin glargine differs from human insulin by replacing asparagine with glycine in position 21 of the A-chain and by carboxy-terminal extension of B-chain by 2 arginine residues. The arginine amino acids shift the isoelectric point from a pH of 5.4 to 6.7, making the molecule more soluble at an acidic pH and less soluble at physiological pH. The isoelectric shift also allows for the subcutaneous injection of a clear solution. The glycine substitution prevents ] of the acid-sensitive asparagine at acidic pH. In the neutral subcutaneous space, higher-order aggregates form, resulting in a slow, peakless dissolution and absorption of insulin from the site of injection.<ref name="Bolli">{{cite journal | vauthors = Bolli GB, Di Marchi RD, Park GD, Pramming S, Koivisto VA | title = Insulin analogues and their potential in the management of diabetes mellitus | journal = Diabetologia | volume = 42 | issue = 10 | pages = 1151–1167 | date = October 1999 | pmid = 10525654 | doi = 10.1007/s001250051286 | doi-access = free }}</ref> |
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International clinical studies have confirmed the advantages of insulin glargine in the treatment of heavy hypoglycaemia compared to standard NPH insulin. Insulin glargine reduces the risk of severe nocturnal hypoglycaemia. Extensive clinical studies (ACCORD) have confirmed the higher risk of mortality with higher incidence of severe hypoglycaemia.<ref>, Action to Control Cardiovascular Risk in Diabetes (ACCORD), Trial , June 6, 2008</ref><ref>, Effects of Intensive Glucose Lowering in Type 2 Diabetes</ref> A comparison trial of insulin detemir and glargine proved that subjects randomized to detemir used slightly higher daily insulin doses, but gained less weight on average than glargine-treated subjects.<ref name="Postgraduate Medicine 2010">{{cite journal | author=L. Raymond Reynolds, MD, FACP, FACE, ECNU | title=Comparing Insulins Detemir and Glargine in Type 2 Diabetes: More Similarities than Differences | journal=Postgraduate Medicine | month=January | year=2010 | pages=201–203 | volume=122 | issue=1 | url=http://www.postgradmed.com/index.php?article=2116 | doi=10.3810/pgm.2010.01.2116 | pmid=20107306}}</ref> Other systematic reviews corroborate the results of benefit of insulin glargine regarding lower incidence of severe hypoglycaemia.<ref name="pmid19221352">{{cite journal |author=Singh SR, Ahmad F, Lal A, Yu C, Bai Z, Bennett H |title=Efficacy and safety of insulin analogues for the management of diabetes mellitus: a meta-analysis |journal=CMAJ |volume=180 |issue=4 |pages=385–97 |year=2009 |month=February |pmid=19221352 |pmc=2638025 |doi=10.1503/cmaj.081041 |url=http://www.cmaj.ca/cgi/pmidlookup?view=long&pmid=19221352}}</ref> |
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==History== |
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On June 13, 2009, Diabetologia, the journal of ] (EASD), published the results of a 5 year long-term observational, retrospective analysis. During the study no other safety issues, such as unexpected adverse events for either insulin emerged. However, insulin glargine was associated with a lower incidence of severe hypoglycaemia compared with NPH insulin.<ref name="pmid19526210">{{cite journal |author=Rosenstock J, Fonseca V, McGill JB, Riddle M, Hallé JP, Hramiak I, Johnston P, Davis M.|title=Similar progression of diabetic retinopathy with insulin glargine and neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes: a long-term, randomised, open-label study |journal=Diabetologia |date=13 June 2009|pmid=19526210 |url=http://www.springerlink.com/content/c4352jj00640558p/fulltext.pdf |volume=52 |issue=9 |pages=1778–88 |doi=10.1007/s00125-009-1415-7 |pmc=2723680}}</ref> |
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In June 2000, the European Commission formally approved the launching of Lantus by Sanofi-Aventis Germany in the European Union.<ref>{{cite web | title=Lantus EPAR | website=] (EMA) | date=8 May 2009 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/lantus | access-date=7 May 2020 | archive-date=4 August 2020 | archive-url=https://web.archive.org/web/20200804155233/https://www.ema.europa.eu/en/medicines/human/EPAR/lantus | url-status=live }}</ref> The admission was prolonged on 9 June 2005.<ref> {{webarchive|url=https://web.archive.org/web/20061122101428/http://www.emea.europa.eu/humandocs/PDFs/EPAR/Lantus/061500de1.pdf |date=22 November 2006 }}, German summary of admission report of the ] (PDF)</ref> |
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A three-fold more concentrated formulation, brand name Toujeo, was introduced after FDA approval in 2015.<ref>{{cite press release |url=http://www.news.sanofi.us/2015-02-25-Sanofi-Receives-FDA-Approval-of-Once-Daily-Basal-Insulin-Toujeo|title=Sanofi Receives FDA Approval of Once-Daily Basal Insulin Toujeo|publisher=Sanofi|date=25 February 2015|url-status=live|archive-url=https://web.archive.org/web/20150227175634/http://www.news.sanofi.us/2015-02-25-Sanofi-Receives-FDA-Approval-of-Once-Daily-Basal-Insulin-Toujeo|archive-date=27 February 2015}}</ref><ref>{{cite web | title=Toujeo: FDA-Approved Drugs | website=U.S. ] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206538 | access-date=7 May 2020 | archive-date=14 August 2020 | archive-url=https://web.archive.org/web/20200814020233/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206538 | url-status=live }}</ref> |
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==Possible cancer link== |
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On June 26, 2009, Diabetologia published the results of four large-scale registry studies from Sweden, Germany, Scotland and the rest of the UK. The German study, of around 127,000 insulin-treated patients from an insurance database, suggested a possible link between insulin glargine (Lantus) and increased risk of developing cancer.<ref name="pmid19565214">{{cite journal |author=Hemkens LG et al|title=Risk of malignancies in patients with diabetes treated with human insulin or insulin analogues: a cohort study|journal=Diabetologia |date=26 June 2009|pmid=19565214 |doi=10.1007/s00125-009-1418-4 |volume=52 |issue=9 |pages=1732–44 |pmc=2723679}}</ref> The risk of cancer was dose-dependent, with those taking higher doses of Lantus apparently at increased risk.<ref>http://webcast.easd.org/press/glargine/transcript.htm</ref> Whilst the authors stressed the limitations of the study and recommended that patients prescribed Lantus continue to take the drug, the results led to the EASD making "''an urgent call for more research into a possible link between use of insulin glargine (an insulin analogue, brand name Lantus) and increased risk of cancer''."<ref>http://www.diabetologia-journal.org/cancer.html</ref> |
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== Legal status == |
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The ] responded, stating that the results of the four studies were inconsistent, and that a relationship between insulin glargine and cancer could neither be confirmed nor excluded.<ref name=EMEA1> European Medicines Agency update on safety of insulin glargine, June 29, 2009</ref> They announced that they would undertake further detailed assessment of the studies’ results and any other relevant information, including several potential ] that had not been fully taken into account by the studies. Patients being treated with insulin glargine were advised to continue their treatment as normal. |
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=== Biosimilars === |
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<ref name=EMEA1/> The following month, the EMEA reported back, concluding that "''the available data does not provide a cause for concern and that changes to the prescribing advice are therefore not necessary''.”<ref> European Medicines Agency update on safety of insulin glargine, July 23, 2009</ref> |
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Abasaglar was approved for medical use in the European Union in September 2014.<ref>{{cite web | title=Abasaglar EPAR | website=] (EMA) | date=14 October 2014 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/abasaglar-previously-abasria#authorisation-details-section | access-date=28 July 2021 | archive-date=2 April 2022 | archive-url=https://web.archive.org/web/20220402171234/https://www.ema.europa.eu/en/medicines/human/EPAR/abasaglar-previously-abasria#authorisation-details-section | url-status=live }}</ref><ref>{{cite web | title=Abasaglar Product information | website=Union Register of medicinal products | date=11 September 2014 | url=https://ec.europa.eu/health/documents/community-register/html/h944.htm | access-date=1 October 2023}}</ref> |
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Lusduna was approved for medical use in the European Union in January 2017.<ref>{{cite web | title=Lusduna EPAR | website=] (EMA) | date=12 January 2017 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/lusduna | access-date=28 July 2021 | archive-date=29 July 2021 | archive-url=https://web.archive.org/web/20210729050001/https://www.ema.europa.eu/en/medicines/human/EPAR/lusduna | url-status=live }}</ref> |
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The ] (ADA) also responded to the Diabetologia report, describing the published registry studies as “conflicting and confusing” and “inconclusive”. They advised patients against discontinuing Lantus and warned against "over-reaction".<ref> Statement from the American Diabetes Association Related to Studies Published in 'Diabetologia', June 26, 2009</ref> |
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In March 2018, insulin glargine (Semglee) was approved for medical use in the European Union.<ref name="Semglee EPAR">{{cite web | title=Semglee EPAR | website=] (EMA) | date=23 May 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/semglee | access-date=28 July 2021 | archive-date=15 February 2022 | archive-url=https://web.archive.org/web/20220215172501/https://www.ema.europa.eu/en/medicines/human/EPAR/semglee | url-status=live }}</ref> |
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==References== |
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<references/> |
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In July 2021, insulin glargine-yfgn (Semglee) was approved for medical use in the United States as the first interchangeable biosimilar of Lantus.<ref name="FDA PR 20210728">{{cite press release | title=FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes | website=U.S. ] (FDA) | date=28 July 2021 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes | access-date=28 July 2021 | archive-date=28 August 2021 | archive-url=https://web.archive.org/web/20210828201228/https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes | url-status=live }} {{PD-notice}}</ref> The FDA granted approval of Semglee to ].<ref name="FDA PR 20210728" /> |
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==== Patent expiry ==== |
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Patent protection for insulin glargine expired in Europe and the US in 2014.<ref name=patent>{{cite web | title=Biosimilars of insulin glargine | publisher= GaBI Generics and Biosimilars Initiative | date=27 November 2020 | url=https://gabionline.net/biosimilars/general/Biosimilars-of-insulin-glargine}}</ref> Insulin glargine from competitor ] became available in most countries during 2015, under the brand names Basaglar (as a follow-on in the US) and Abasaglar (as a biosimilar in the EU).<ref name=patent/> |
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=== Brand names === |
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Insulin glargine is available under brand names including Basaglar, Lantus, and Toujeo. |
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== References == |
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{{reflist}} |
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==External links== |
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* - ] |
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* (Sanofi-Aventis) |
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{{Oral hypoglycemics and insulin analogs}} |
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{{Oral hypoglycemics and insulin analogs}} |
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{{Eli Lilly and Company}} |
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{{Portal bar | Medicine}} |
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{{Authority control}} |
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{{DEFAULTSORT:Insulin Glargine}} |
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{{DEFAULTSORT:Insulin Glargine}} |
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